CA2999201C - Compositions orales de taxane et procedes associes - Google Patents

Compositions orales de taxane et procedes associes Download PDF

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Publication number
CA2999201C
CA2999201C CA2999201A CA2999201A CA2999201C CA 2999201 C CA2999201 C CA 2999201C CA 2999201 A CA2999201 A CA 2999201A CA 2999201 A CA2999201 A CA 2999201A CA 2999201 C CA2999201 C CA 2999201C
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Prior art keywords
pharmaceutical composition
taxane
docetaxel
polysorbate
tween
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CA2999201A
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CA2999201A1 (fr
Inventor
Denise S.B. Chan
Ming Tsung Lee
Weng Li Yoon
Johnson Yiu-Nam Lau
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Athenex HK Innovative Ltd
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Athenex HK Innovative Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/472—Non-condensed isoquinolines, e.g. papaverine
    • A61K31/4725—Non-condensed isoquinolines, e.g. papaverine containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dispersion Chemistry (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

L'invention concerne une composition pharmaceutique comprenant une taxane (par exemple, le paclitaxel, le docétaxel, le cabazitaxel, le larotaxel, l'ortataxel, et/ou le tésétaxel) dans un mélange d'un premier et d'un second tensioactif. L'absorption de la taxane est augmentée à partir de la composition pharmaceutique et est supérieure à la somme de l'absorption du docétaxel à partir du premier ou du second tensioactif. L'augmentation de l'absorption est particulièrement améliorée lorsque le rapport entre le premier tensioactif et le second tensioactif dans la composition pharmaceutique se situe entre 60/40 et 85/15 en poids, le poids total des tensioactifs ne dépassant pas 98 % du poids total. Le polysorbate 80, le polysorbate 20 et des polyoxylglycérides de caprylocaproyle servent en tant que premiers tensioactifs appropriés, et le polysorbate 80 ou l'huile de ricin polyéthyoxylée sert en tant que second tensioactif approprié. La stabilité de la composition pharmaceutique peut être améliorée par ajout ultérieur d'un stabilisant (par exemple, de l'acide citrique et/ou de l'acide ascorbique).
CA2999201A 2015-09-30 2016-09-29 Compositions orales de taxane et procedes associes Active CA2999201C (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562234868P 2015-09-30 2015-09-30
US62/234,868 2015-09-30
PCT/CN2016/100807 WO2017054754A1 (fr) 2015-09-30 2016-09-29 Compositions orales de taxane et procédés associés

Publications (2)

Publication Number Publication Date
CA2999201A1 CA2999201A1 (fr) 2017-04-06
CA2999201C true CA2999201C (fr) 2024-02-06

Family

ID=58408671

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2999201A Active CA2999201C (fr) 2015-09-30 2016-09-29 Compositions orales de taxane et procedes associes

Country Status (12)

Country Link
US (2) US10835511B2 (fr)
EP (1) EP3355881B1 (fr)
JP (2) JP6985276B2 (fr)
KR (1) KR102656954B1 (fr)
CN (2) CN108697683B (fr)
AU (2) AU2016333292B2 (fr)
CA (1) CA2999201C (fr)
ES (1) ES2904691T3 (fr)
HK (1) HK1258390A1 (fr)
MX (1) MX386381B (fr)
TW (3) TWI838700B (fr)
WO (1) WO2017054754A1 (fr)

Families Citing this family (12)

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TWI838700B (zh) * 2015-09-30 2024-04-11 香港商慧源香港創新有限公司 口服紫杉烷組合物及方法
US10188626B2 (en) * 2015-11-03 2019-01-29 Cipla Limited Stabilized cabazitaxel formulations
EP3773581A4 (fr) * 2018-04-13 2021-12-29 Athenex Therapeutics Limited Combinaisons thérapeutiques de paclitaxel et d'un inhibiteur de p-gp à administration par voie orale pour le traitement de l'angiosarcome
EP3793523B8 (fr) * 2018-05-15 2026-01-21 The United States of America, as represented by the Secretary, Department of Health and Human Services Formulations et méthodes de prévention et de traitement des métastases tumorales et de la tumorigenèse
CA3112060A1 (fr) * 2018-10-12 2020-04-16 Advanced Accelerator Applications International Sa Composition pharmaceutique comprenant un antagoniste de gprp radiomarque et un tensioactif
EP3893867A1 (fr) * 2018-12-14 2021-10-20 Athenex HK Innovative Limited Combinaisons thérapeutiques de docétaxel et d'un inhibiteur de a p-gp administré par voie orale pour le traitement du cancer
JP2023520273A (ja) * 2020-01-24 2023-05-17 トゥヴァルディ セラピューティクス，インク． 治療化合物、製剤、およびその使用
TWI900672B (zh) 2020-10-07 2025-10-11 香港商希華醫藥有限公司 乙醯胺基－苯基四唑衍生物及其使用方法
EP4241761A4 (fr) * 2020-11-09 2024-09-25 Scai Therapeutics Co., Ltd. Cyclosporine a solide et composition de dispersion la comprenant
CN116406256A (zh) * 2020-11-09 2023-07-07 思凯制药有限公司 固体物质和包含其的分散组合物
CN116350619B (zh) * 2021-12-28 2025-04-08 北京抗创联生物制药技术研究有限公司 一种口服紫杉烷类药物组合物
CN118045200B (zh) * 2024-02-27 2025-07-18 中国海洋大学 具有p糖蛋白抑制功能的纳米药物载体、制备方法及应用

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TWI838700B (zh) * 2015-09-30 2024-04-11 香港商慧源香港創新有限公司 口服紫杉烷組合物及方法

Also Published As

Publication number Publication date
US20210023042A1 (en) 2021-01-28
US10835511B2 (en) 2020-11-17
ES2904691T3 (es) 2022-04-05
HK1258390A1 (zh) 2019-11-08
TW202114653A (zh) 2021-04-16
BR112018006510A2 (pt) 2018-10-09
TW202227048A (zh) 2022-07-16
KR102656954B1 (ko) 2024-04-12
AU2016333292B2 (en) 2021-11-11
TWI715636B (zh) 2021-01-11
MX386381B (es) 2025-03-18
AU2016333292A1 (en) 2018-04-12
EP3355881A1 (fr) 2018-08-08
WO2017054754A1 (fr) 2017-04-06
MX2018003452A (es) 2018-09-06
JP7227334B2 (ja) 2023-02-21
TWI838700B (zh) 2024-04-11
NZ740759A (en) 2024-10-25
EP3355881B1 (fr) 2021-12-08
TW201711680A (zh) 2017-04-01
CA2999201A1 (fr) 2017-04-06
EP3355881A4 (fr) 2019-05-08
US20170087121A1 (en) 2017-03-30
AU2022200919B2 (en) 2024-03-07
JP2018529778A (ja) 2018-10-11
KR20180093880A (ko) 2018-08-22
TWI752750B (zh) 2022-01-11
US11963942B2 (en) 2024-04-23
JP6985276B2 (ja) 2021-12-22
CN108697683B (zh) 2021-09-17
JP2022016636A (ja) 2022-01-21
CN113521002B (zh) 2022-12-13
AU2022200919A1 (en) 2022-03-03
CN108697683A (zh) 2018-10-23
CN113521002A (zh) 2021-10-22

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